510(k) K911664 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
DIRECTIGEN 1-2-3 PREGNANCY CONTROLS
| Applicant | Quidel Corp., San Diego CA, US |
| Decision | Substantially Equivalent, May 31, 1991 |
| Received | Apr 12, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911664
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.